AccessGUDID - DEVICE: Olympus (04042761034890)

GUDID

Device Identifier (DI) Information

Brand Name: Olympus
Version or Model: A02959A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A02959A
Company Name: OLYMPUS Winter & Ibe GmbH

Primary DI Number: 04042761034890
Issuing Agency: GS1
Commercial Distribution End Date: February 16, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 316957240 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65798	Hard-tissue ultrasonic surgical system holder/tip guide	A hand-held component of an ultrasonic surgical system intended to guide/direct the tip of the system’s holder/tip (not included) which oscillates (vibrates) on hard tissue (e.g., bone) during open or minimally-invasive surgery. It typically has a tubular form with a handle, and may have an elongated distal end to maintain a distance (offset) between its most distal point and the cutting tissue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGB	Ureteroscope And Accessories, Flexible/Rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K951855	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7aed4d83-ef1f-4022-936d-b0168b184082
Public Version Date: August 18, 2022
Public Version Number: 4
DI Record Publish Date: September 21, 2016